Clozapine use in patients with pre-existing Sinus Tachycardia and Right Atrial Enlargement as found on ECG

Response to this request is long overdue. By law, under all circumstances, Medicines and Healthcare products Regulatory Agency should have responded by now (details). You can complain by requesting an internal review.

name removed 23 Oct 2012 (Account suspended)

30 December 2011

Dear Medicines and Healthcare products Regulatory Agency,

I would be grateful if you could respond via Whatdotheyknow website to the following Freedom of Information Request. Thank you very much.

I cannot find any specific information on this although I have looked into several websites. There is information about Clozapine's possible side-effects, but nothing to state whether or not a patient should actually begin the clozapine programme with a pre-existing Sinus Tachycardia and Right Atrial Enlargement as found on ECG.

1 What is the safe dose of Clozapine for a person with pre-existing Sinus Tachycardia and Right Atrial Enlargement as found on ECG?

2 What is the safe dose of Clozapine and of Bisoprolol for a person with pre-existing Sinus Tachycardia and Right Atrial Enlargement as found on ECG?

3 When should the registered Responsible Clinician and registered pharmacist inform the drug company that the registered patient on the national register of clozapine drug users has Sinus Tachycardia and Right Atrial Enlargement?

4] Is it contraindicated for a person with pre-existing Sinus Tachycardia and Right Atrial Enlargement as found on ECG to be started on clozapine at all?

5] And if it is acceptable, what specific monitoring and checks should be made?

6] And is it all right to give Lorazepam with Bisoprolol and Clozapine to a patient with pre-existing Sinus Tachycardia and Right Atrial Enlargement as found on ECG?

7] When should the patient see a cardiac specialist, if at all?

Thank you very much for your help in this matter as it could well improve safety in drugs medication to know your answers to my questions.

Yours sincerely,

[first name removed] [last name removed]

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the MHRA. This automated response confirms
that we have received your email and that it will be dealt with as quickly
as possible.

You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:

[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Manufacturer’s and wholesale dealer’s licences:
[3]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[4]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[5]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[6]http://www.mhra.gov.uk/Howweregulate/Med...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

***Please note that the Agency is closed on the 26^th, 27^th & 28^th
December. We are also closed on the 2^nd January. We are open on the 29^th
& 30^th December, and our opening hours will be 09:00 – 16:00.***

Kind regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
message.

Coming soon: We will be conducting a survey of our Enquiry Point, seeking
your views on the service we provide and any enhancements you would like
to see. Click here for further information: [7]Central Enquiry Point.

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/Contactus/Central...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Med...
4. http://www.mhra.gov.uk/Howweregulate/Dev...
5. http://www.mhra.gov.uk/Safetyinformation...
6. http://www.mhra.gov.uk/Howweregulate/Med...
7. http://www.mhra.gov.uk/Contactus/Central...

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 12/002

Dear Ms [last name removed],

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 31st December 2011.


I confirm that your request is being handled under the Freedom of
Information Act and you should receive a reply within 20 working days
from our date of receipt.

If you need to contact us again about this request, please quote the
reference number above.

Yours Sincerely

Central Enquiry Point
Information Services
MHRA
Tel: 020 3080 6000

show quoted sections

FOILicensing, Medicines and Healthcare products Regulatory Agency

3 Attachments

Dear Ms [last name removed]

Please find attached our response to the above-referenced Freedom of
Information request.

Yours sincerely

FOI Licensing

<<FOI 12_002.doc>> <<Clozaril 25mg Tablets SmPC.pdf>> <<Clozaril 100mg
Tablets SmPC.pdf>>
P please don't print this e-mail unless you really need to.

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

name removed 23 Oct 2012 (Account suspended)

Dear MHRA Licensing, Medicines and Healthcare products Regulatory Agency,

Thank you very much for responding to me with your response to my FOI Request.

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Medicines and Healthcare products Regulatory Agency's handling of my FOI request 'Clozapine use in patients with pre-existing Sinus Tachycardia and Right Atrial Enlargement as found on ECG'.

In my original Freedom of Information Request I was requesting to know specifically whether or not Clozapine should be given to a heart patient who has been identified, BEFORE administration of Clozapine/Clozaril, with Sinus Tachycardia and Right Atrial Enlargement.

Whilst I note what you have stated, I believe that you have not provided me with the essential information I have requested:

namely, is it SAFE to have Clozapine with a pre-existing heart condition?

And, if it is safe, how is it determined to be safe?

You have given me an "overview" but I do need specific information as that has not been provided to me anywhere - NICE stated that they did not have the information and if you cannot give me precise information - who can?

I have asked several bodies and professionals but nobody has the specific answers to what I have asked.

Yet it could potentially be fatal if patients and doctors and pharmacists alike are kept in the dark about serious complications. A false sense of security might arise between the patients and clinicians and pharmacists, with tragic consequences.

I note that you state that the drug companies ONLY look for agranulocytosis.

I wish to register my specific concern and complaint about this because it is identified that Clozapine - and you admit this yourself - can have the potential to cause very serious circulatory effects.

If the heart is not monitored at the same frequency as the agranulocytosis tests, is it not thereby possible that some people might be developing "silent" heart problems of significance when patients - and even their clinicians and pharmacists - might not be aware of the dangers because their hearts are not regularly and very frequently monitored?

For this reason I wish to raise a yellow card anonymous concern about Clozapine being given to any patient with pre-existing Right Atrial enlargement and Sinus Tachycardia as found on ECG.

For I wish to know just how serious IS

a] Sinus Tachycardia - found on more than one occasion - in fact consequent on a long regular pattern of fast heartbeat over a few weeks

b] Right Atrial Enlargement

I have personal experience of someone who had been on beta-blockers for palpitations being given Avandia in 2000 - only to develop LVF - but not being removed from it even with this condition - and was continued to be prescribed it "off label" for the next 5 years as it was contraindicated in heart failure or history of heart failure.

And it is this that makes me scared of Clozaril.

And why I wish to get a national moratorium on the safety of this drug - at the very least I believe that the Drug Companies, responsible clinicians and pharmacists should ensure that a weekly ECG be taken of all Clozaril patients in the same way that blood tests are taken for the first number of weeks. And then if patients are continued on Clozaril beyond that specific period of time, then each and every time a blood test is taken, that an ECG should be taken of the heart at the SAME TIME.

And that the drug companies, the responsible clinicians, the responsible pharmacists and the patients should all be alerted to the COMPREHENSIVE results of the patients INDIVIDUAL responses to Clozapine, not just agranulocytosis.

A full history of my FOI request and all correspondence is available on the Internet at this address:
http://www.whatdotheyknow.com/request/cl...

Yours sincerely,

[first name removed] [last name removed]

Campaigner for Liberty, Truth and Liberty

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the MHRA. This automated response confirms
that we have received your email and that it will be dealt with as quickly
as possible.

You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:

[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials of medicines:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:

[3]http://www.mhra.gov.uk/Howweregulate/Dev...

Manufacturer’s and wholesale dealer’s licences:
[4]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[5]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[6]http://www.mhra.gov.uk/Safetyinformation...

Reporting an adverse incident involving a medical device:

[7]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[8]http://www.mhra.gov.uk/Howweregulate/Med...

Regulation of medical devices:

[9]http://www.mhra.gov.uk/Howweregulate/Dev...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

Coming soon: We will be conducting a survey of our Enquiry Point, seeking
your views on the service we provide and any enhancements you would like
to see. Click here for further information: [10]Central Enquiry Point.

Kind regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
message.

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/Contactus/Central...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Howweregulate/Dev...
10. http://www.mhra.gov.uk/Contactus/Central...

Jones, Sue, Medicines and Healthcare products Regulatory Agency

Dear Ms [last name removed]
 
I am writing to inform you that I am dealing with your request for a
review of FOI 12-002 which you made on 27th January 2012.  I realise that
the response is already overdue, for which I apologise, but I intend to
get a response to you by Friday 9th March at the latest.
I will also be dealing with your requests for reviews numbered FOI 12-046
and 12-024 and intend to get you responses to these also by 9th March.  If
there is likely to be any further delay, I will let you know.
 
Sue Jones
MHRA
151 Buckingham Palace Road
London SW1W 9SZ
 
 
Please do not print this message unless you have to
 
 
 
 
 

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

Jones, Sue, Medicines and Healthcare products Regulatory Agency

1 Attachment

Dear Ms  [last name removed]
 
I attach the full response to your request for an internal review of FOI
12-002.  I apologise for the delay in dealing with this request.
 
 
 
Sue Jones
MHRA
151 Buckingham Palace Road
London SW1W 9SZ
 
 
Please do not print this message unless you have to
 
 
 
 
 

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

name removed 23 Oct 2012 (Account suspended)

8 April 2012

Dear Ms Jones, MHRA, Department of Health, Mr Lansley Secretary of State for Health, Mr Turner MP for the Isle of Wight and Mr Cameron Prime Minister of Great Britain and Northern Ireland,

SINUS TACHYCARDIA AND RIGHT ATRIAL ENLARGEMENT

I thank the MHRA and Ms Jones for the response to my request for information and for the internal review undertaken.

I am writing again to request a full review into my requests for information as I still have not been given the information I have specifically sought, although what I have been sent is very useful indeed, I STILL do not know if Sinus Tachycardia and Right Atrial Enlargement is a major condition or trivial - and until someone specifically explains this to me, I shall keep asking to be given the information.

Despite specifically requesting what precisely is Right Atrial Enlargement coupled with persistent pattern of Sinus Tachycardia - even with Bisoprolol added to the Clozapine - I have singularly NOT been informed whether it is a minor problem and inconsequential, or is of a minor to middling problem needing some oversight or whether it is a major heart condition.

I fear that the public are not being made fully aware of what actually is their condition if they

a] have regular pattern of sinus tachycardia

b] have right atrial heart enlargement

c] are given clozapine without seeing a heart specialist to ensure that the right atrial heart enlargement and sinus tachycardia can nevertheless withstand the toxicological effects of the major and potentially lethal clozapine at whatever dose

d] already have right atrial enlargement and parkinsonism associated with amisulpride and then given the two drugs together to cross-titrate and then the patient develops fine tremor and akithesia - is this not the time to see a heart specialist and be referred by the inpatient's Responsible Clinician and Pharmacist who have care and control of a patient on the National Clozaril Program in any event?

What are the liabilities in law for a medical team to prescribe toxic drugs "off label"?

How does a patient complain where the responsible authorities seek to remove the patient from their Nearest Relative who brings to the attention their MAJOR CONCERNS about Clozapine to the Responsible Clinician's attention, but who then BARS the Nearest Relative for daring to complain about the proposed treatment, notwithstanding that the said patient already has been exhibiting significant sinus tachycardia on Olanzapine for over 4 weeks according to another, unrelated, clinician?

To me, this is playing games - Russian Roulette - with people's lives.

Please explain to me how you allow such a thing to happen.

Thank you very much for your internal review but it simply does not address the key issues I asked - namely HOW DANGEROUS IS IT TO GIVE CLOZAPINE - AND TO CONTINUE TO GIVE IT AND NOT STOP IT - TO A PATIENT WHO HAS SINUS TACHYCARDIA AND RIGHT ATRIAL ENLARGEMENT OF THE HEART.

Is a regular Sinus Tachycardia a major heart problem and if so what is the cause and how is it mended?

Is Right Atrial Enlargement a major heart problem and if so what is the cause and how is it mended? Can Right Atrial Enlargement occur

a] with Olanzapine after 8 weeks?
b] with Amisulpride after 4 weeks?
c] with Amisulpride and Clozapine cross-titration after a week or so?

I am most concerned for people with heart conditions and believe that there should be a "black box" on Clozapine to warn ALL patients and their relatives and Nearest Relatives of the absolute dangers associated with this drug because at least one Responsible Clinician has prescribed Clozapine in the known context of Right Atrial Enlargement and Sinus Tachycardia. Should the Responsible Clinician be questioned by MHRA as to why this was done or do you not involve yourselves in such matters? And if not, who do I ask to investigate?

I believe it to be in the public interest for ALL Responsible Clinicians to explain properly why they act in the way they do and not be secretive either towards their patients or their relatives, for we are talking here of some of the MOST VULNERABLE patients in the whole of the United Kingdom, those who are deemed in need of such a toxicological drug that the benefits must outweigh the disbenefits.

What point is there for a mental problem to be resolved at the risk of death, as in Catherine Bell's instance where the Coroner's Decision of December 2011 specifically referred to her death in the context of Clozapine?

I believe strongly that we need a NATIONAL MORATORIUM on the safety of Clozapine in particular and Olanzapine and Amisulpride in the context of people who have sinus tachycardia and / or Right atrial enlargement of the heart.

To me this is cardinal.

Thank you very much for your help,

I look forward to having response from you all,

With my gratitude,

[first name removed] [last name removed]

Campaigner for liberty, truth and justice

Jones, Sue, Medicines and Healthcare products Regulatory Agency

Dear Ms [last name removed]

I am writing in response to your request for a further internal review of questions you have asked. Firstly, in this e-mail you do not refer to any specific FOI request that you have made on this matter - and there are several. If you are asking for a review of a specific request, you need to identify that request, and then give specific reasons on what grounds you are asking for the review, e.g. if information has been withheld under any of the exemptions under the FOI Act. You cannot use a request for a review to raise new questions that you have not asked before, as you seem to be in the message below.
If you have new questions, then these should be made as a new FOI request and made through the MHRA Central Enquiry Point.

For the reasons given above, this request below is not being treated as a request for an internal review. If you wish the new questions you raise to be treated as a new FOI then you should re submit them as a new request accordingly.

Yours sincerely

Sue Jones
Policy Division
MHRA

show quoted sections

name removed 23 Oct 2012 (Account suspended)

9 March 2012

Dear Ms Jones, FOI Review Team, Mr Turner MP for the Isle of Wight, Mr Lansley Secretary of State for Health, Lord Howe Minister for Health and Parliamentary Under Secretarty to the Department of Health and Mr Cameron Prime Minister of Great Britain and Northern Ireland,

I am writing to request a review of my entire correspondence with the MHRA vis-a-vis "Clozapine use in patients with Sinus Tachycardia and Right Atrial Enlargement".

I believe that the MHRA's latest response from Ms Jones to my request completely obscures my request for information.

My whole FOI was about Clozapine use with patients suffering Sinus Tachycardia and Right Atrial Enlargement.

The information produced to me specifically skirted round the question about these conditions, mentioning only that serious heart conditions needed to be checked by a cardiac consultant before initiation with Clozapine.

Far from my NOT asking questions, as Ms Jones said I did not, I did ask questions again, but rephrasing them so that they could be made clearer for the MHRA to realise what was still OUTSTANDING from my original request.

Clozapine use in patients with pre-existing Sinus Tachycardia and Right Atrial Enlargement as found on ECG.

WHAT IS RIGHT ATRIAL ENLARGEMENT AND SINUS TACHYCARDIA? IS IS A MAJOR HEART PROBLEM?
Should a patient with such a presentation NOT have Clozapine in any event?

Thank you very much

[first name removed] [last name removed]

Campaigner for legal reform, liberty, truth and justice

30 December 2011

Dear Medicines and Healthcare products Regulatory Agency,

I would be grateful if you could respond via Whatdotheyknow website to the following Freedom of Information Request. Thank you very much.

I cannot find any specific information on this although I have looked into several websites. There is information about Clozapine's possible side-effects, but nothing to state whether or not a patient should actually begin the clozapine programme with a pre-existing Sinus Tachycardia and Right Atrial Enlargement as found on ECG.

1 What is the safe dose of Clozapine for a person with pre-existing Sinus Tachycardia and Right Atrial Enlargement as found on ECG?

2 What is the safe dose of Clozapine and of Bisoprolol for a person with pre-existing Sinus Tachycardia and Right Atrial Enlargement as found on ECG?

3 When should the registered Responsible Clinician and registered pharmacist inform the drug company that the registered patient on the national register of clozapine drug users has Sinus Tachycardia and Right Atrial Enlargement?

4] Is it contraindicated for a person with pre-existing Sinus Tachycardia and Right Atrial Enlargement as found on ECG to be started on clozapine at all?

5] And if it is acceptable, what specific monitoring and checks should be made?

6] And is it all right to give Lorazepam with Bisoprolol and Clozapine to a patient with pre-existing Sinus Tachycardia and Right Atrial Enlargement as found on ECG?

7] When should the patient see a cardiac specialist, if at all?

Thank you very much for your help in this matter as it could well improve safety in drugs medication to know your answers to my questions.

Yours sincerely,

[first name removed] [last name removed]

From: [first name removed] [last name removed]

8 March 2012

Dear Ms Jones, MHRA, Department of Health, Mr Lansley Secretary of State for Health, Mr Turner MP for the Isle of Wight and Mr Cameron Prime Minister of Great Britain and Northern Ireland,

SINUS TACHYCARDIA AND RIGHT ATRIAL ENLARGEMENT

I thank the MHRA and Ms Jones for the response to my request for information and for the internal review undertaken.

I am writing again to request a full review into my requests for information as I still have not been given the information I have specifically sought, although what I have been sent is very useful indeed, I STILL do not know if Sinus Tachycardia and Right Atrial Enlargement is a major condition or trivial - and until someone specifically explains this to me, I shall keep asking to be given the information.

Despite specifically requesting what precisely is Right Atrial Enlargement coupled with persistent pattern of Sinus Tachycardia - even with Bisoprolol added to the Clozapine - I have singularly NOT been informed whether it is a minor problem and inconsequential, or is of a minor to middling problem needing some oversight or whether it is a major heart condition.

I fear that the public are not being made fully aware of what actually is their condition if they

a] have regular pattern of sinus tachycardia

b] have right atrial heart enlargement

c] are given clozapine without seeing a heart specialist to ensure that the right atrial heart enlargement and sinus tachycardia can nevertheless withstand the toxicological effects of the major and potentially lethal clozapine at whatever dose

d] already have right atrial enlargement and parkinsonism associated with amisulpride and then given the two drugs together to cross-titrate and then the patient develops fine tremor and akithesia - is this not the time to see a heart specialist and be referred by the inpatient's Responsible Clinician and Pharmacist who have care and control of a patient on the National Clozaril Program in any event?

What are the liabilities in law for a medical team to prescribe toxic drugs "off label"?

How does a patient complain where the responsible authorities seek to remove the patient from their Nearest Relative who brings to the attention their MAJOR CONCERNS about Clozapine to the Responsible Clinician's attention, but who then BARS the Nearest Relative for daring to complain about the proposed treatment, notwithstanding that the said patient already has been exhibiting significant sinus tachycardia on Olanzapine for over 4 weeks according to another, unrelated, clinician?

To me, this is playing games - Russian Roulette - with people's lives.

Please explain to me how you allow such a thing to happen.

Thank you very much for your internal review but it simply does not address the key issues I asked - namely HOW DANGEROUS IS IT TO GIVE CLOZAPINE - AND TO CONTINUE TO GIVE IT AND NOT STOP IT - TO A PATIENT WHO HAS SINUS TACHYCARDIA AND RIGHT ATRIAL ENLARGEMENT OF THE HEART.

Is a regular Sinus Tachycardia a major heart problem and if so what is the cause and how is it mended?

Is Right Atrial Enlargement a major heart problem and if so what is the cause and how is it mended? Can Right Atrial Enlargement occur

a] with Olanzapine after 8 weeks?
b] with Amisulpride after 4 weeks?
c] with Amisulpride and Clozapine cross-titration after a week or so?

I am most concerned for people with heart conditions and believe that there should be a "black box" on Clozapine to warn ALL patients and their relatives and Nearest Relatives of the absolute dangers associated with this drug because at least one Responsible Clinician has prescribed Clozapine in the known context of Right Atrial Enlargement and Sinus Tachycardia. Should the Responsible Clinician be questioned by MHRA as to why this was done or do you not involve yourselves in such matters? And if not, who do I ask to investigate?

I believe it to be in the public interest for ALL Responsible Clinicians to explain properly why they act in the way they do and not be secretive either towards their patients or their relatives, for we are talking here of some of the MOST VULNERABLE patients in the whole of the United Kingdom, those who are deemed in need of such a toxicological drug that the benefits must outweigh the disbenefits.

What point is there for a mental problem to be resolved at the risk of death, as in Catherine Bell's instance where the Coroner's Decision of December 2011 specifically referred to her death in the context of Clozapine?

I believe strongly that we need a NATIONAL MORATORIUM on the safety of Clozapine in particular and Olanzapine and Amisulpride in the context of people who have sinus tachycardia and / or Right atrial enlargement of the heart.

To me this is cardinal.

Thank you very much for your help,

I look forward to having response from you all,

With my gratitude,

[first name removed] [last name removed]

Campaigner for liberty, truth and justice

"9 March 2012
Dear Ms [last name removed]

I am writing in response to your request for a further internal review of questions you have asked. Firstly, in this e-mail you do not refer to any specific FOI request that you have made on this matter - and there are several. If you are asking for a review of a specific request, you need to identify that request, and then give specific reasons on what grounds you are asking for the review, e.g. if information has been withheld under any of the exemptions under the FOI Act. You cannot use a request for a review to raise new questions that you have not asked before, as you seem to be in the message below.
If you have new questions, then these should be made as a new FOI request and made through the MHRA Central Enquiry Point.

For the reasons given above, this request below is not being treated as a request for an internal review. If you wish the new questions you raise to be treated as a new FOI then you should re submit them as a new request accordingly.

Yours sincerely

Sue Jones
Policy Division
MHRA"

Yours sincerely,

[first name removed] [last name removed]

Jones, Sue, Medicines and Healthcare products Regulatory Agency

1 Attachment

 
 
Dear Mrs [last name removed]
Please find attached the report on the review of FOI request 12-046.
 
Yours sincerely
 
Sue Jones
MHRA Policy Division
 

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

name removed 23 Oct 2012 (Account suspended)

13 March 2011

Dear Ms Jones MHRA, Mr Turner MP for the Isle of Wight, Mr Lansley Secretary of State for Health, Mr Pickles Secretary of State, Mr Cameron Prime Minister of Great Britain and Northern Ireland,

I thank you very much, Ms Jones, for your thoroughness in assessing this internal review of my Freedom of Information Request.

To me, the importance in all of this is health and safety for the public.

That to me is vital. My mother is no longer alive, but I know that she was very concerned lest other people might have similar traumatic experiences and asked me to lobby to make hoists safe. She was terrified of being hoisted - and with good reason.

A "universal" sling is NOT NECESSARILY actually able to be used in universal circumstances. This is what I have been campaigning about.

a] Why are "universal" slings on sale?

I was told by MHRA that one reason why they did not investigate further was that the MHRA had told the company in question NOT to use the word "universal" - but even in 2011 these slings were on sale. Why?

b] In 2008 why did MHRA accept that the universal sling could be used safely with the crossbar when in fact an email to the MHRA stated that so long as it was a straight bar it was all right to use on the gantry hoist?

To me this is at the heart of it all.

I have emailed the MHRA with details of this.

c] I want it to be demonstrated to me specifically how the specific universal sling and the specific crossbar and the specific gantry hoist in use on 24 June 2006 can actually be risk-assessed as SAFE to use, in view of what was sent to the MHRA in 2008 stating that it had to be a straight bar.

d] It is very important because the local authority records have a record stating that it must have been the carer's mistake. I believe this to be wrong and mischievous as the person writing it was part of the assessment. I believe that the assessment was not properly done, as can be seen in the correspondence you have.

I believe that slings which have holes in them are dangerous as simple as that.

I would be most grateful to have the MHRA's full report on this matter sent to me. You have my email address and home address.

I have been in contact with the South London Coroner's because my mother died 9 days after the adverse incident which specifically was NOT recorded by the local authority but their excuse was that they did not witness it and therefore they did not see any requirement to let anyone know. To me, this is wrong.

I wish to have a proper report so that I may evaluate it as the Executrix of my late mother. It may be that the South London Coroner will want a copy if there are sufficient grounds to investigate further.

Thank you very much for your help.

I look forward to hearing from you in the near future.

Yours sincerely,

[first name removed] [last name removed]

Campaigner for liberty, truth and justice

Date 12 th March 2012
REVIEW OF FREEDOM OF INFORMATION ACT (FOIA) REQUEST FOI 12-046

1. INTRODUCTION
1.1 In an email dated 15/11/11 (sent via whatdotheyknow.com), Mrs [last name removed] requested a review of the Medicines and Healthcare products Regulatory Agency’s (MHRA) response to the request relating to the Committee on the Safety of Devices (CSD), again sent via whatdotheyknow.com, on 30/10/11.

“I would like to know if the Committee on the Safety of Devices has been given information regarding a very serious incident on 24 June 2006 which specifically involved a specific Gantry Hoist, a specific Crossbar Spreader Bar and a specific sling provided by a local authority, which risk-assessed the combination?”
1.2 The MHRAs response was sent on 2 November 2011. Mrs [last name removed] also asked, in an email dated 4th March 2012 what is happening to her complaint in respect of this issue. I apologise for the delay in dealing with this review.

2. PURPOSE OF INTERNAL REVIEW
2.1 The purpose of this internal review is to determine whether the MHRA dealt properly with the applicant’s requests under the Freedom of Information Act (FOIA) in its response.
The terms of reference of this review are:
• To read all correspondence between the applicant and the Agency, and any other relevant correspondence;
• To form an opinion on the handling of the correspondence by the Agency;
• To advise whether the actions taken by the Agency in reaching their decisions is justified under the FOIA;
• To make recommendations for further action by the Agency if appropriate; and
• To prepare a report of the review for the Agency and Mrs [last name removed].

3. Background

3.1 The Agency’s response to Mrs [last name removed]’s request was as follows:
“The Committee members would not have been made aware of this particular incident, which I note happened some time ago. Committee members do not investigate specific incidents. Investigation of reported incidents is carried out by MHRA device specialists and all information is collated through our adverse incident centre. As I am sure you are aware hoists are covered by very specific safety regulations. Could you please confirm that the incident below was reported to us? If you can provide more information then I may be able to help further.”

3.2 This seems to me to be a clear and unequivocal response to the initial question asked, and should have concluded this FOI request. Had the MHRA acted correctly and logged this as an FOIA request initially, this could have been done.

3.3 Instead, in a follow up email dated 02/11/11, Mrs [last name removed] asked:
“I would like clarification whether it is or is not a requirement as of 24 June 2006 onwards for the local authority to inform the MHRA once they were informed of the incident.”
To which the Agency replied on 10/11/11

"Under the Medical device Regulations there is a mandatory requirement on medical device manufacturers to report adverse incidents involving their devices which resulted or had the potential to result in serious injury or death to users.

Although we encourage and welcome reports from users [healthcare professionals, patients, members of the public etc.]there is no legal requirement for this and reports are made on a voluntary basis."

3.4 This reply elicited yet a further question from Mrs [last name removed] on 11/11/11
“In which case could you please confirm that the two manufacturers in this particular incident did inform you and when did they do so?”

3.5 This question does not appear to have been answered, at least via the FOIA.

3.6 These emails effectively formed an ongoing discussion regarding Agency policy towards the safety of slings and hoists, e.g. requesting reviews and further investigations. Eventually, on 15 November, Mrs [last name removed] requested an internal review. This request was repeated on 21st November, 14th and 24th December, and 22nd January. These requests were all met by an automated answering service informing her that she would be answered when the recipient returned to work.

3.7 On 23rd December the situation was further confused when Mrs [last name removed] was notified that her request for an internal review had been referred and treated as a complaint. Understandably this served to confuse the matter and the requester. The complaints process should not have been employed to deal with the request for an internal review. Again, had the initial request been properly handled this would not have occurred.

4. CONSIDERATION OF THE ISSUES
Handling of the initial request:

4.1 Mrs [last name removed]’s initial request was never logged or dealt with as a request under the FOIA. It was only brought within the scope of the Act when a further request for internal review was sent on 23rd January and came to the attention of the Agency’s FOI officer. At this point the request was logged as an FOIA request in order that it could be internally reviewed as such.

4.2 The initial request dated 30th October should have been logged and processed as an FOIA request in the normal way, despite the question having apparently been answered. In the Agency’s defence the initial request was probably dealt with as a routine business enquiry as it was answered quickly and in full. Although all requests for information fall within the remit of the FOIA, it would be impractical to treat every request received as being an FOIA request given that the Agency processes many thousands of requests for various types of information every year in the course of normal business.

4.3 However, given that the request was submitted via the whatdotheyknow.com website, and Mrs. [last name removed] indicated clearly on 15th November that she considered her request to be an FOIA request, something should have been done much sooner than 23rd January.

4.4 This would also have allowed the Agency to deal with the request in a more focused way and to separate out the elements of her correspondence that were applicable to the FOIA, and those which were not.

4.5 What unfolded from the date of the first request is a somewhat confusing and ongoing dialogue mixing requests for information, with complaints, and requests for actions completely outside the remit of the Act.
The Freedom of Information Act (FOIA)
4.6 The FOIA confers two basic rights to a requester:
• To be informed if the information is held
• To receive that information (subject to any relevant exemptions)
These rights apply to information held by a public authority.

4.7 The initial request was answered and, had it been processed correctly, the subsequent answer would have closed the request. Subsequent questions would then have been dealt with as new FOIA requests, rather than parts of an ongoing dialogue.

4.8 As this was not done at the time, I have looked at those elements of the correspondence which are properly FOIA requests to determine what further action is required.
Request dated 30/10/11

4.9 “I would like to know if the Committee on the Safety of Devices has been given information regarding a very serious incident on 24 June 2006 which specifically involved a specific Gantry Hoist, a specific Crossbar Spreader Bar and a specific sling provided by a local authority, which risk-assessed the combination?”
• This request has been answered

Request dated 02/11/11
4.10 “I would like clarification whether it is or is not a requirement as of 24 June 2006 onwards for the local authority to inform the MHRA once they were informed of the incident.”
• This request has been answered

Request dated 02/11/11
4.11 “I had no idea that the MANUFACTURERS had to inform you of incidents rather than the prescribers of the sling, crossbar and hoist.
In which case could you please confirm that the two manufacturers in this particular incident did inform you and when did they do so?”
• I can find no indication that this request has been answered and I have asked the relevant section to provide it within 20 days.

4.12 Anything within the correspondence, other than a request for information held, is outside the remit of the FOIA. Therefore I have confined my review to what I believe are relevant requests under the Act.

4.13 However, I feel it important to point out that while the FOIA can allow access to information, and the complaints process can oblige us to review whether we have correctly followed procedures, neither of them is really a mechanism for bringing about change as such. Consequently, other matters arising from the correspondence, such as a perceived need for the creation of national policies, investigations into local authority practices, reviews about incident reporting etc, are not within the remit of the FOIA or the complaints process to address, and are issues that should be pursued by other means.

5. SUMMARY
• The Agency was at fault in not having initially dealt with the request as an FOIA request, and in not taking relevant action on the numerous requests for an internal review which followed.

• The unanswered request of 02/02/11 will be processed (as part of the initial request) and the answer provided to Mrs [last name removed] within 20 working days.
For these errors, I would like to apologise to Mrs [last name removed]."

name removed 23 Oct 2012 (Account suspended)

13 March 2012

Dear Ms Jones, MHRA,

I have mistakenly written to you under the wrong FOI for which I apologise.

I will repeat it on the correct form.

Thank you very much for your help which is much appreciated,

Yours sincerely,

[first name removed] [last name removed]

name removed 23 Oct 2012 (Account suspended)

Dear Medicines and Healthcare products Regulatory Agency,

Please may I ask for an internal review of all my requests about Clozapine use in patients with Right Atrial Enlargement to be considered de novo, as I still have NOT been told if RIGHT ATRIAL ENLARGEMENT is or is not a serious heart condition.

If it is only trivial, and inconsequential please let me know.

Similarly, if regular tachycardia has to be treated with Bisoprolol, is it safe to use Clozapine?

And if a person has atrophied frontal lobes, is it safe to have Clozapine?

And if the only checks that are done by the Pharmacy treating a person with Clozapine is for BLOOD TESTS, how can they ENSURE that NO HEART problems will affect the patient because unless frequent monitoring of the heart is done at one and the same time, it is possible that a person might die.

I am very concerned that people might be developing "silent" heart disease so that while the patients are rightly being checked for agranulocytosis, they are NOT automatically being checked for their physical symptoms of any heart tachycardia or right atrial enlargement or heart failure AS BY RIGHTS, but only if the clinician believes it to be necessary.

As some people are compulsorily medicated with Clozapine this therefore might mean iatrogenically induced illness by dint of medicating with a known toxicological substance.

Catherine Bell's death was decided in the Coroner's Decision as reported in December 2011 to be related to Clozapine.

I believe that Clozapine should carry a black box warning and that all patients not only should have frequent blood checks but at one and the same time frequent HEART MONITORING.

Otherwise I fear that people might die unnecessarily.

I wish there to be a public moratorium on the use of Clozapine and antipsychotics in general as there are serious potential side-effects with some of these drugs of choice being prescribed in the UK with the sanction of NICE, DH AND MHRA.

Remember that Thalidomide was once regarded as a wonder drug.

And look at the tragic consequences that were unforeseen as a result.

But here you have a drug which has had KNOWN fatal consequences, and yet you still license this drug.

Thank you for your help,

Yours sincerely,

[first name removed] [last name removed]

Campaigner for legal reform, liberty, truth and justice

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the MHRA. This automated response confirms
that we have received your email and that it will be dealt with as quickly
as possible.

You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:

[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials of medicines:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:

[3]http://www.mhra.gov.uk/Howweregulate/Dev...

Manufacturer’s and wholesale dealer’s licences:
[4]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[5]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[6]http://www.mhra.gov.uk/Safetyinformation...

Reporting an adverse incident involving a medical device:

[7]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[8]http://www.mhra.gov.uk/Howweregulate/Med...

Reporting a counterfeit medical product:

[9]http://www.mhra.gov.uk/Safetyinformation...

Buying medicines over the internet:

[10]http://www.mhra.gov.uk/Safetyinformation...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

Kind regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
message.

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/Contactus/Central...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Safetyinformation...
10. http://www.mhra.gov.uk/Safetyinformation...

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 12/166

Dear Enquirer,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 14 March 2012.

I confirm that your request is being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

show quoted sections

name removed 23 Oct 2012 (Account suspended)

10 April 2012

Dear MHRA Central Enquiry Point, Mr Turner MP for the Isle of Wight, Mr Lansley Secretary of State for Health and Lord Howe Parliamentary Under Secretary to the Ministry of Health, Information Commissioner,

I thank the MHRA for acknowledging receipt of one of my postings of an enquiry which has been given the number FOI 12/166 which they received on 14 March 2012.

[request for requester's personal information removed]

Thank you very much for your help,

Yours sincerely,

[first name removed] [last name removed]

Campaigner for legal reform, liberty, truth and justice

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the MHRA. This automated response confirms
that we have received your email and that it will be dealt with as quickly
as possible.

You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:

[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials of medicines:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:

[3]http://www.mhra.gov.uk/Howweregulate/Dev...

Manufacturer’s and wholesale dealer’s licences:
[4]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[5]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[6]http://www.mhra.gov.uk/Safetyinformation...

Reporting an adverse incident involving a medical device:

[7]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[8]http://www.mhra.gov.uk/Howweregulate/Med...

Reporting a counterfeit medical product:

[9]http://www.mhra.gov.uk/Safetyinformation...

Buying medicines over the internet:

[10]http://www.mhra.gov.uk/Safetyinformation...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

Kind regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
message.

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/Contactus/Central...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Safetyinformation...
10. http://www.mhra.gov.uk/Safetyinformation...

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

1 Attachment

Dear Mrs [last name removed],
       
Thank you for your enquiry to the MHRA.
 
Attached is the request to your FOI request.
 
 
               
Kind Regards,
 
 
Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000
 
 
 
 
 
 
 
 
 

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

name removed 23 Oct 2012 (Account suspended)

11 April 2012

Dear MHRA Central Enquiry Point, Whatdotheyknow team, Mr Turner MP for the Isle of Wight, Information Commissioner,

[complaint about supply of requester's personal information removed.]

Thank you very much for your help,

Yours sincerely,

[first name removed] [last name removed]

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

1 Attachment

Dear Mrs [last name removed],
       
Thank you for your enquiry to the MHRA.
 
Attached is the response to your FOI request.
 
        
       
Kind Regards,
 
 
Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000
 
 
 
 
 
 
 
 
 

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the MHRA. This automated response confirms
that we have received your email and that it will be dealt with as quickly
as possible.

You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:

[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials of medicines:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:

[3]http://www.mhra.gov.uk/Howweregulate/Dev...

Manufacturer’s and wholesale dealer’s licences:
[4]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[5]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[6]http://www.mhra.gov.uk/Safetyinformation...

Reporting an adverse incident involving a medical device:

[7]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[8]http://www.mhra.gov.uk/Howweregulate/Med...

Reporting a counterfeit medical product:

[9]http://www.mhra.gov.uk/Safetyinformation...

Buying medicines over the internet:

[10]http://www.mhra.gov.uk/Safetyinformation...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

Kind regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
message.

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/Contactus/Central...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Safetyinformation...
10. http://www.mhra.gov.uk/Safetyinformation...

Sent a follow up to Medicines and Healthcare products Regulatory Agency again.

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the MHRA. This automated response confirms
that we have received your email and that it will be dealt with as quickly
as possible.

You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:

[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials of medicines:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:

[3]http://www.mhra.gov.uk/Howweregulate/Dev...

Manufacturer’s and wholesale dealer’s licences:
[4]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[5]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[6]http://www.mhra.gov.uk/Safetyinformation...

Reporting an adverse incident involving a medical device:

[7]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[8]http://www.mhra.gov.uk/Howweregulate/Med...

Reporting a counterfeit medical product:

[9]http://www.mhra.gov.uk/Safetyinformation...

Buying medicines over the internet:

[10]http://www.mhra.gov.uk/Safetyinformation...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

Kind regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
message.

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.mhra.gov.uk/Contactus/Central...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Safetyinformation...
10. http://www.mhra.gov.uk/Safetyinformation...

Ben Harris left an annotation ()

Parts of the request above have been removed because they were requests for the requester’s own personal information, which is not an appropriate use of WhatDoTheyKnow.

The re-sending of a follow-up above was a result of a mistake on my part while editing this request. MHRA have been informed of the mistake.

--
Ben Harris, WhatDoTheyKnow volunteer.

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Dear Mrs [last name removed],

Following on from your email below about removing information from the 'whatdotheyknow' website, we would advise you to contact their Website Administrators directly as they are best placed to assist you. MHRA has no control over the content of that website.

We hope you find this useful.


Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

show quoted sections

Richard Taylor left an annotation ()

When "viewed as HTML" two attachments sent in response to this request thread showed the name of someone unrelated to this correspondence in the page titles.

This has been removed, in line with our policies on trivial takedowns.

--

Richard - WhatDoTheyKnow.com volunteer

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

1 Attachment

Dear Mrs [last name removed],
       
Thank you for your enquiry to the MHRA.
 
Attached is the response to your FOI request.
       
       
Kind Regards,
 
Ronke
Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000
 
 
 
 
 

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

 

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

 

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

Ben Harris left an annotation ()

[name removed] has told us that she has referred this request to the Information Commissioner.

--
Ben Harris, WhatDoTheyKnow volunteer.

Looking for an EU Authority?

You can request documents directly from EU Institutions at our sister site AskTheEU.org . Find out more .

AskTheEU.org